Study of ALXN1820 in Healthy Adult Participants
Study Identifier:
ALXN1820-HV-101
ClinicalTrials.gov Identifier:
EudraCT Identifier:
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1820 SC
- Drug: ALXN1820 IV
- Drug: Placebo SC
- Drug: Placebo IV
Date
Jan 2021 - Sep 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
- Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
- Satisfactory medical assessment.
- Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
- Vaccination requirement:
- Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
- Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.
Exclusion Criteria
- Current/recurrent diseases or relevant medical history.
- History of any Neisseria infection.
- Hepatitis B/C, human immunodeficiency virus.
- History of latent or active tuberculosis (TB), or positive TB test.
- Active systemic infection within 14 days of dosing.
- Risk of meningococcal infections due to living/working conditions.
- History of complement deficiency or complement activity below the reference range.
- Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
- Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
- Acquired complement deficiencies (for example, those receiving eculizumab).
Sex
Female & Male
Age
N/A
Study Details
Medical Condition
- Other
Study Drug
- Drug: ALXN1820 SC
- Drug: ALXN1820 IV
- Drug: Placebo SC
- Drug: Placebo IV
Date
Jan 2021 - Sep 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: N/A years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- Body weight 50 to 100 kilograms (kg); body mass index 17 to 32 kg/meter squared.
- Cohort 9 only: Japanese participants (defined as those participants whose parents and grandparents are both Japanese and who have spent less than 5 years outside of Japan).
- Satisfactory medical assessment.
- Must follow protocol-specified contraception guidance while on treatment and for up to 6 months after last dose.
- Vaccination requirement:
- Vaccination with tetravalent meningococcal conjugate vaccine at least 56 days and not more than 2 years, 6 months prior to dosing;
- Vaccination with serogroup B meningococcal vaccine at least 56 days prior to dosing, with a booster at least 28 days prior to dosing, with at least 28 days between the first and second injections.
Exclusion Criteria
- Current/recurrent diseases or relevant medical history.
- History of any Neisseria infection.
- Hepatitis B/C, human immunodeficiency virus.
- History of latent or active tuberculosis (TB), or positive TB test.
- Active systemic infection within 14 days of dosing.
- Risk of meningococcal infections due to living/working conditions.
- History of complement deficiency or complement activity below the reference range.
- Participation in a clinical study within 90 days or 5 half lives of the investigational agent (whichever is longer) before initiation of dosing on Day 1.
- Participation in more than 1 clinical study of a monoclonal antibody (mAb), or participation in a clinical study of a mAb within the 6 months or 5 half lives of the mAb (whichever is longer) prior to screening.
- Acquired complement deficiencies (for example, those receiving eculizumab).
Protocol Summary
This is a Phase 1, randomized, double-blind, placebo-controlled single and multiple ascending dose study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of ALXN1820 administered subcutaneously (SC) (ALXN1820 SC) and intravenously (IV) (ALXN1820 IV).
Trial Locations
Location
Status
Location
Research Site
Herston, Australia, 4006
Status
N/A
Location
Research Site
London, United Kingdom, SE1 1YR
Status
N/A
Location
Research Site
London, United Kingdom, SE5 9RS
Status
N/A